JOB TITLE: VP/Director Mechanical Product Development
LOCATION:
Miami, Florida
Company Name:
HeartWare, Inc.
Location: Miami Lakes, Florida
Company: HeartWare, Inc. Advance Product Development Department
Company Profile: HeartWare International, Inc. (HeartWare) is a medical device company developing a family of implantable Left Ventricular Assist Devices ("LVADs") for the treatment of advanced heart failure. Heart failure is a degenerative, terminal disease affecting over 20 million patients worldwide. Approximately 1 million patients suffer from Class IV heart failure, the end stage of the disease. Heart transplantation is considered the best available treatment option, but only approximately 3,000 donor hearts become available worldwide each year. LVADs are used to bridge patients until a donor heart becomes available (so called Bridge-to-Transplant therapy) or, increasingly, as a long term alternative to transplantation (so called Destination Therapy.) The HeartWare Ventricular Assist System features a miniaturized implantable centrifugal pump (named the HVAD) capable of producing up to 10 liters per minute of blood flow. The pump is designed to be implanted above the diaphragm, directly adjacent to the heart, thereby avoiding the abdominal surgery generally required to implant competing devices. The HVAD small size is achieved by careful integration of the hydraulic, mechanical, and electrical subsystems. HeartWare is also developing a portfolio of further miniaturized devices, implantable by progressively less invasive surgery. HeartWare's corporate headquarters are in Framingham, Massachusetts. The Company's development and manufacturing activities are based in Miami Lakes, Florida.
Description: HeartWare has an immediate opening for a high caliber professional to lead the growing mechanical product development group. This individual will report to the Chief Scientific Officer of the Company, and will be responsible for providing technical and managerial leadership related to product development of mechanical systems and associated sustaining engineering. The ideal candidate will work in the early identification of technical and project management risks associated to product development including the creation of contingency plans. Other responsibilities are the development and control of product specifications for internal and external manufacturing and the establishment and implementation of tactical and strategic plans. The individual will be also responsible for ensuring compliance with the Company’s Design Control Standard Operating Procedures. Excellent interpersonal skills are required as the position engages in a high level of cross functional team work with clinical, marketing, sales, quality, regulatory, process development and manufacturing groups. The candidate will also be responsible for managing external relationships with vendors, potential vendors, customers, research organizations and test facilities.
Requirements:
Education: MS or PHD in Mechanical, Biomedical or Aeronautical Engineering.
Experience: Minimum of 20 years, with at least 10 years in product development of commercially successful hydraulic-thermal-mechanical systems (e.g., continuous flow medical pumps, industrial pumps or turbines, membrane oxygenators, fuel cells and engines). Experience in applied research technology development is preferable. Directorship and managerial “hands on” experience and proven record of product safety and on-time performance are also required.
Skills and Abilities: Demonstrated ability to provide leadership on product development in fast paced, and technology challenging commercial environments. Demonstrated ability to provide strategic and critical thinking guidance related to product development and sustaining engineering issues. Ability to work in a regulated design control environment and to communicate with senior management, investors, clinicians, external researchers, and industry professionals is a must. Excellent communication skills are necessary, both verbal and written, along with exceptional project management skills with emphasis in project synchronization with external and internal resources. Strong interpersonal skills are a must.
We offer competitive compensation and a challenging work environment. We foster cross functional team work, and provide career development opportunities. Some relocation assistance may be available.
Date this job was posted: October 26, 2009
Why you should ignore this date
How to Apply:
Interested candidates should email a cover letter and a resume to:
Employment@heartwareinc.com
We are an EEO employer
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HeartWare, Inc.
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